Linking Infectious and Narcology Care (LINC) in Russia: design, intervention and implementation protocol.
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SUBMITTER: Gnatienko N
PROVIDER: S-EPMC4855723 | biostudies-literature | 2016 May
REPOSITORIES: biostudies-literature
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Linking Infectious and Narcology Care (LINC) in Russia: design, intervention and implementation protocol.
Gnatienko Natalia N Han Steve C SC Krupitsky Evgeny E Blokhina Elena E Bridden Carly C Chaisson Christine E CE Cheng Debbie M DM Walley Alexander Y AY Raj Anita A Samet Jeffrey H JH
Addiction science & clinical practice 20160504 1
<h4>Background</h4>Russia and Eastern Europe have one of the fastest growing HIV epidemics in the world. While countries in this region have implemented HIV testing within addiction treatment systems, linkage to HIV care from these settings is not yet standard practice. The Linking Infectious and Narcology Care (LINC) intervention utilized peer-led strengths-based case management to motivate HIV-infected patients in addiction treatment to obtain HIV care. This paper describes the protocol of a r ...[more]
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Project description:BackgroundIf Russia is to achieve the UNAIDS 90-90-90 HIV targets, better approaches to engage, effectively treat, and retain patients in care are needed. This paper describes the protocol of a randomized controlled trial (RCT) testing the effectiveness of LINC-II, a strength-based case management program for HIV-positive people who inject drugs (PWID) to increase rates of HIV viral suppression, ART initiation, and opioid abstinence.MethodsThis RCT will enroll and randomize 240 participants, recruited from a narcology (addiction care) hospital in St. Petersburg, Russia. Participants are randomized to the intervention or control arms. Those in the intervention arm receive: (1) strengths-based HIV case management supporting coordinated care; (2) rapid ART initiation; and (3) pharmacotherapy for opioid use disorder. We will evaluate the intervention's effectiveness compared to standard of care on the following outcomes: (1) undetectable HIV viral load at 12 months (primary); (2) initiation of ART within 28 days of randomization; (3) change in CD4 count from baseline to 12 months; (4) retention in HIV care (i.e., ≥ 1 visit to medical care in 2 consecutive 6 month periods); (5) undetectable HIV viral load at 6 months; and (6) past 30-day opioid abstinence (at 6 and at 12 months).DiscussionThis RCT will assess the LINC-II intervention in an urban Russian setting. If effective, it will offer a new approach for increasing the uptake of both HIV and opioid use disorder treatment and coordination of these modalities in standard Eastern European clinical settings. Trial registration This study was registered with ClinicalTrials.gov through the National Institutes of Health, NCT03290391. Registered 19 September 2017, https://clinicaltrials.gov/ct2/show/NCT03290391.
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Project description:Background: The current COVID-19 coronavirus pandemic is an emergency on a global scale, with huge swathes of the population required to remain indoors for prolonged periods to tackle the virus. In this new context, individuals' health-promoting routines are under greater strain, contributing to poorer mental and physical health. Additionally, individuals are required to keep up to date with latest health guidelines about the virus, which may be confusing in an age of social-media disinformation and shifting guidelines. To tackle these factors, we developed Elena+, a smartphone-based and conversational agent (CA) delivered pandemic lifestyle care intervention. Methods: Elena+ utilizes varied intervention components to deliver a psychoeducation-focused coaching program on the topics of: COVID-19 information, physical activity, mental health (anxiety, loneliness, mental resources), sleep and diet and nutrition. Over 43 subtopics, a CA guides individuals through content and tracks progress over time, such as changes in health outcome assessments per topic, alongside user-set behavioral intentions and user-reported actual behaviors. Ratings of the usage experience, social demographics and the user profile are also captured. Elena+ is available for public download on iOS and Android devices in English, European Spanish and Latin American Spanish with future languages and launch countries planned, and no limits on planned recruitment. Panel data methods will be used to track user progress over time in subsequent analyses. The Elena+ intervention is open-source under the Apache 2 license (MobileCoach software) and the Creative Commons 4.0 license CC BY-NC-SA (intervention logic and content), allowing future collaborations; such as cultural adaptions, integration of new sensor-related features or the development of new topics. Discussion: Digital health applications offer a low-cost and scalable route to meet challenges to public health. As Elena+ was developed by an international and interdisciplinary team in a short time frame to meet the COVID-19 pandemic, empirical data are required to discern how effective such solutions can be in meeting real world, emergent health crises. Additionally, clustering Elena+ users based on characteristics and usage behaviors could help public health practitioners understand how population-level digital health interventions can reach at-risk and sub-populations.
| S-EPMC8566727 | biostudies-literature
Project description:BackgroundEvidence-based HIV interventions often fail to reach anticipated impact due to insufficient utilization in real-world health systems. Human-centered design (HCD) represents a novel approach in tailoring innovations to fit end-users, narrowing the gap between efficacious interventions and impact at scale.MethodsWe combined a narrative literature review of HCD in HIV programs with our experience using HCD to redesign an intervention promoting patient-centered care (PCC) practices among health care workers (HCW) in Zambia. We summarize the use and results of HCD in the global HIV response and share case study insights to advance conceptualization of HCD applications.ResultsThe literature review identified 13 articles (representing 7 studies) on the use of HCD in HIV. All studies featured HCD hallmarks including empathy development, user-driven inquiry, ideation, and iterative refinement. HCD was applied to mHealth design, a management intervention and pre-exposure prophylaxis delivery. Our HCD application addressed a behavioral service delivery target: changing HCW patient-centered beliefs, attitudes, and practices. Through in-depth developer-user interaction, our HCD approach revealed specific HCW support for and resistance to PCC, suggesting intervention revisions to improve feasibility and acceptability and PCC considerations that could inform implementation in transferable settings.ConclusionsAs both a research and implementation tool, HCD has potential to improve effective implementation of the HIV response, particularly for product development; new intervention introduction; and complex system interventions. Further research on HCD application strengths and limitations is needed. Those promoting PCC may improve implementation success by seeking out resonance and anticipating the challenges our HCD process identified.
| S-EPMC6880397 | biostudies-literature
Project description:IntroductionPatients with long-term conditions consistently report a lack of information around services and support available to them. This unmet need for information is significant among people with dementia and family carers. A quality improvement intervention is being carried out to tackle this issue as part of a co-creation initiative in the North East of England (UK). The intervention consists of the dissemination (via the local Community Mental Health Services for Older People) of a leaflet about services available to people with dementia and their family carers in the study site. This protocol is reported in accordance with the Standards for Reporting Implementation Studies.Methods and analysisThis effectiveness-implementation hybrid type 2 study aims at understanding (1) the unfolding and outcomes of the implementation strategy, (2) the outcomes of the intervention (for people with dementia and family carers, staff implementing the intervention and local service providers) and (3) the contribution of co-creation to the design and implementation of the intervention and its outcomes. The prospective theory of change of the intervention articulated by local stakeholders is used as a reference framework against which to assess the implementation and outcomes of the intervention. Evaluation data will be collected through in-depth interviews with people with dementia and family carers receiving the intervention, staff implementing the intervention and managers from local service providers. Referral data from local service providers will be collected to triangulate the interview data. A focus group with key stakeholders will support the sense-making of findings. The realist configuration of mechanism-context-outcome, operationalised using an information behaviour model, will inform data analysis and interpretation.Ethics and disseminationEthical and research governance approvals have been obtained from the West Midlands-South Birmingham Research Ethics Committee. The results of the study will be submitted for publication in peer-reviewed journals and disseminated through conferences.
| S-EPMC7725094 | biostudies-literature
Project description:BackgroundDepression affects millions of people all over the world and implies a great socioeconomic burden. Despite there are different effective evidence-based interventions for treating depression, only a small proportion of these patients receives an appropriate treatment. In this regard, information and communication technologies (ICTs) can be used with therapeutic aims and this can contribute to make interventions more accessible. One example is "Smiling is fun", an internet-based treatment which has proved to be effective and cost-effective for treating depression in Spanish Primary Care (PC). However, the "know-do gap" between research and clinical settings implies that the actual implementation of such interventions could last up to 20 years. To overcome this obstacle, the implementation research establishes the methodology to implement the advances developed in the laboratories to the health care services maintaining the validity of the intervention and offering specific strategies for the implementation process.ObjectiveThis is the protocol of an implementation study for the Internet-based program "Smiling is fun", which will be conducted on patients with mild-to-moderate depression of Spanish PC settings. In the implementation study, the feasibility, efficacy, cost-efficacy, acceptability, adoption, appropriateness, fidelity, penetration, normalization, and sustainability will be assessed.MethodsThe current investigation is a Hybrid Effectiveness-Implementation Type II design. A Stepped Wedge randomized controlled trial design will be used, with a cohort of 420 adults diagnosed with depression (mild-to-moderate) who will undergo a first control phase (no treatment) followed by the intervention, which will last 16 weeks, and finishing with an optional use of the intervention. All patients will be assessed at baseline, during the treatment, and at post-treatment. The study will be conducted in three Spanish regions: Andalusia, Aragon, and the Balearic Islands. Two primary care centers of each region will participate, one located in the urban setting and the other in the rural setting. The primary outcome will be implementation success of the intervention assessing the reach, clinical effect, acceptability, appropriateness, adoption, feasibility, fidelity, penetration, implementation costs and sustainability services.Discussion"Smiling is Fun", which has already been established as effective and cost-effective, will be adapted according to users' experiences and opinions, and the efficacy and cost-efficacy of the program will again be assessed. The study will point out barriers and facilitators to consider in the implementation process of internet-based psychological interventions in health services. The ultimate goal is to break the research-to-practice split, which would undoubtedly contribute to reduce the high burden of depression in our society.Trial registrationClinicalTrials.gov, Identifier: NCT05294614.
| S-EPMC9789354 | biostudies-literature
Project description:BackgroundMajor depressive disorder (MDD) is a serious public health concern worldwide. A treatment approach that incorporates measurement-based care (MBC) and shared decision-making between patients with MDD and their providers may foster patient engagement and improve clinical outcomes. While digital tools such as mobile apps show promise for expanding health interventions, these apps are rarely integrated into clinical practice.ObjectiveThe primary objective of this ongoing study is to determine whether implementation of a digital tool-the Pathway Platform-in primary care improves adherence to MBC practices; here, we present the study methods.MethodsThis large-scale, real-world implementation study is based on a pilot study of an earlier iteration of a mobile app (the Pathway app) that confirmed the feasibility of using the app in patients with MDD and showed a positive trend in patient engagement in the app arm. In addition, a user-centered design approach that included qualitative assessments from patients and providers was used to improve understanding of the patient journey and care team workflows. User feedback highlighted the need for enhanced features, education modules, and real-time data sharing via integration with the electronic health record. The current iteration of the Platform includes the newest version of the Pathway app, education modules for both patients and providers, and real-time patient-level data sharing with the electronic health record. The study takes place in primary care sites within the Advocate Aurora Health system in Illinois and includes adult patients with MDD who were recently prescribed monotherapy antidepressant medication (defined as a new start, medication switch, or dose change in the past 3 months). Clinical performance and selected patient outcomes will be compared before and after the implementation of the Platform.ResultsPatient recruitment was completed in July 2022, with initial results expected in mid-2023.ConclusionsThis study will provide useful insights into real-world integration of a digital platform within a large health system. The methods presented here highlight the unique user-centric development of the Pathway Platform, which has resulted in an enhanced digital tool with the potential to foster MBC and shared decision-making, improve patient-provider communication, and ultimately lead to optimized treatment outcomes for patients with MDD.Trial registrationClinicalTrials.gov NCT04891224; https://clinicaltrials.gov/ct2/show/NCT04891224.International registered report identifier (irrid)DERR1-10.2196/43788.
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Project description:BACKGROUND:Binge-drinking in adolescents is a highly prevalent healthcare problem that associates physical and mental health complications with community implications. This paper describes the design, implementation and evaluation of the first web-based computer tailored intervention aimed at the prevention of binge drinking in Spanish adolescents. METHODS:The Alerta Alcohol program is based on the I-Change Model. First, feedback from focus and Delphi groups are used for cultural adaptation and to obtain further information on the items to be included on the program. A pilot study is then conducted to assess feasibility and to identify strengths and weaknesses. Second, a Cluster Randomized Controlled Trial is conducted to test the effectiveness of Alerta Alcohol in students aged 16 to 18 years. The study is performed in 16 high schools from Andalusia (southern Spain), which are randomized either to the experimental or the control condition (EC and CC). The EC receives the Alerta Alcohol intervention, which consists of four sessions at school (baseline questionnaire, two sessions in three scenarios: at home, celebrations, and public places, and a final evaluation). The adolescents are provided with answers related to their views of each scenario; this information is used to provide highly specific feedback regarding their knowledge, risk perception, self-esteem, attitude, social influence, and self-efficacy. In addition, two booster sessions are given at home to reinforce the previous messages. The CC just completes the baseline and the final evaluation questionnaires and then they are allowed to receive the intervention as well (as a waiting list). Evaluation takes place after four months. The primary endpoint is binge drinking within 30 days prior to the evaluation and alcohol use in the previous week. It is expected that Alerta Alcohol reduce the prevalence of binge drinking by 10%. Follow up analyses are carried out to determine the differences in effectiveness according to the compliance of the program (quality of the implementation). DISCUSSION:The results are expected to be applicable and may incorporate improvements in the practice of the Healthcare and Education Systems. If the program proves to be effective, regional and eventual national implementation should be considered. TRIAL REGISTRATION:Trial registration number (ClinicalTrials.gov): NCT03288896 . This study was retrospectively registered on 19/09/2017.
| S-EPMC5885294 | biostudies-literature
Project description:BackgroundGout is a painful chronic disease which disrupts work and family life and can lead to chronic joint damage. Pacific people in Aotearoa/New Zealand experience significant inequities, with over three times the gout prevalence of the non-Pacific non-Māori populations. Pacific people receive less regular urate-lowering drugs to prevent gout flare-ups, and have nine times the hospitalisation from gout compared with non-Pacific non-Māori people. Rates for Indigenous Māori lie between Pacific and non-Pacific non-Māori. A long-established Collective comprising community members from the Pacific People's Health Advisory Group, clinical staff from the Pacific Practice-Based Research Network, and University of Auckland researchers have identified that improving Pacific urate-lowering therapy use as the research question of prime importance for improved health outcomes of Pacific people in South Auckland. Building on the existing knowledge, this study aims to develop, implement and evaluate a novel innovative intervention to improve the uptake of urate-lowering therapy by Pacific patients with gout.MethodsThree-phase mixed methods co-design study using the Fa'afaletui research framework following the STROBE statement. Phase1 is observational times series of prevalence of patients with gout, proportion with urate blood-level monitoring and use of urate-lowering medication over past 5 years. In Phase 2 the Collective will workshop new interventions to address previous uptake barriers, using culturally-appropriate Talanga communications with results synthesised in line with Kakala principles. The designed intervention will be implemented and process and outcome evaluations conducted. Finally, an implementation framework will be produced to facilitate further roll-out.DiscussionThe study aims to enhance health and reduce inequities for Pacific people, contribute to creation of Pacific health knowledge and translation of research findings into Pacific health gains. Potential longer-term impact is a gout-management pathway for use throughout Aotearoa/New Zealand. Māori have similar issues with high gout prevalence and low urate-lowering therapy use hence the intervention is likely to translate to Māori healthcare. The project will contribute to Pacific research capacity and capability-building as well as general upskilling of community and practice members involved in the co-design processes.Trial registrationThe Australian New Zealand Clinical Trial Registry is in process, request number 38206, 1-09-2021.
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Project description:BackgroundOlder Canadians are high users of health care services, however the health care system is not well-designed to meet the complex needs of many older adults. Older persons often look to their primary care practitioners to assess their needs and coordinate their care. The intervention seeks to improve primary care for older persons living with frailty and will be implemented in six primary care clinics in three Canadian provinces. Presently, more than 1.6 million older Canadians are living with frailty, and this is projected to increase to 2.5 million within a decade (Canadian Frailty Network, Frailty Matters, 2020). The model will include frailty screening, an online portal to expedite referrals and improve coordination with community services, and several tools and techniques to support patient and family engagement and shared decision-making. Our project is guided by the Consolidated Framework for Implementation Research (CFIR) (Damschroder LJ, et al. Implement Scil, 4, 50, 2009). As others have done, we adapted the CFIR for our work. Our adapted framework combines elements of the socio-ecological model, key concepts from the CFIR, and elements from other implementation science frameworks. Nested within a broader mixed-method implementation study, the focus of this paper is to outline our guiding conceptual framework and qualitative methods protocol.MethodsWe will use the adapted CFIR framework to inform the data we collect and our analytic approach. Our work is divided into three phases: (1) baseline assessment of 'usual care'; (2) tailoring and implementing a new primary care model; and (3) evaluation. In each of these phases we will engage in qualitative data collection, including clinical observations, focus groups, in-depth interviews and extensive field notes. At each site we will collect data with health care providers, key informants (e.g., executive directors), and rostered patients ≥ 70 years. We will engage in team-based analysis across multiple sites, three provinces and two languages through regular telephone conferences, a comprehensive analysis codebook, leadership from our Qualitative Working Group and a collective appreciation that "science is a team sport" (Clinical Orthopaedics and Related Research 471, 701-702, 2013).DiscussionOutcomes of this research may be used by other research teams who chose to adapt the CFIR framework to reflect the unique contexts of their work, and clinicians seeking to implement our model, or other models of care for frail older patients in primary care.Trial registrationU.S. National Library of Medicine, NCT03442426 . Registered 22 February 2018- Retrospectively registered.
| S-EPMC8336337 | biostudies-literature
Project description:BackgroundIn Nepal, the burden of noncommunicable, chronic diseases is rapidly rising, and disproportionately affecting low and middle-income countries. Integrated interventions are essential in strengthening primary care systems and addressing the burden of multiple comorbidities. A growing body of literature supports the involvement of frontline providers, namely mid-level practitioners and community health workers, in chronic care management. Important operational questions remain, however, around the digital, training, and supervisory structures to support the implementation of effective, affordable, and equitable chronic care management programs.MethodsA 12-month, population-level, type 2 hybrid effectiveness-implementation study will be conducted in rural Nepal to evaluate an integrated noncommunicable disease care management intervention within Nepal's new municipal governance structure. The intervention will leverage the government's planned roll-out of the World Health Organization's Package of Essential Noncommunicable Disease Interventions (WHO-PEN) program in four municipalities in Nepal, with a study population of 80,000. The intervention will leverage both the WHO-PEN and its cardiovascular disease-specific technical guidelines (HEARTS), and will include three evidence-based components: noncommunicable disease care provision using mid-level practitioners and community health workers; digital clinical decision support tools to ensure delivery of evidence-based care; and training and digitally supported supervision of mid-level practitioners to provide motivational interviewing for modifiable risk factor optimization, with a focus on medication adherence, and tobacco and alcohol use. The study will evaluate effectiveness using a pre-post design with stepped implementation. The primary outcomes will be disease-specific, "at-goal" metrics of chronic care management; secondary outcomes will include alcohol and tobacco consumption levels.DiscussionThis is the first population-level, hybrid effectiveness-implementation study of an integrated chronic care management intervention in Nepal. As low and middle-income countries plan for the Sustainable Development Goals and universal health coverage, the results of this pragmatic study will offer insights into policy and programmatic design for noncommunicable disease care management in the future.Trial registrationClinicalTrials.gov, NCT04087369. Registered on 12 September 2019.
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